Month: December 2015

Kentucky Attorney General Jack Conway announced the settlement of two pharmaceutical cases for total of $39.5 million. The settlements end the litigation of the Purdue Pharma case regarding OxyContin and the Johnson & Johnson case regarding Risperdal.

The OxyContin case was settled on Dec. 22 for $24 million – more than 50 times what Kentucky was originally offered in 2007 to settle the case.

The Risperdal case, a consumer protection lawsuit alleging that Johnson & Johnson falsely marketed the drug and hid the side effects from consumers, was settled on Dec. 22 for $15.5 million.

“These companies engaged in reckless behavior that put our citizens at risk,” Attorney General Conway said. “Both companies knowingly and aggressively marketed drugs they knew to be harmful in order to drive profits. I am pleased we were able to recover damages for the Commonwealth and recover funds to help expand addiction treatment in Kentucky.”

Risperdal Settlement

Risperdal is a second-generation antipsychotic prescription drug approved by the FDA to treat schizophrenia and acute mania associated with bipolar disorder. The Kentucky Consumer Protection lawsuit alleged that the makers of Risperdal misled consumers about its dangers and marketed the drug for purposes other than those approved by the FDA. Risperdal is manufactured and distributed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

“Janssen and Johnson & Johnson put patients at risk when they marketed Risperdal without disclosing the drug’s known side effects,” Attorney General Conway said. “These side effects were even more harmful to children and elderly patients.”

Janssen marketed Risperdal to children before it was approved to do so in 2007 by the FDA. It failed to disclose to parents, physicians and patients that Risperdal may cause a hormonal imbalance, which could cause breast tissue development and infertility in both boys and girls. Janssen was aware of the risk and did not update the drug’s warning label because it felt awareness of the risks could cost the company up to $150 million per year.

Janssen also marketed Risperdal for a non-FDA approved use in treating dementia in non-schizophrenic elderly patients. It even created an elder care sales force, despite having its own study that showed Risperdal doubled the risk of death in the elderly. Risperdal’s label did not disclose this risk to the public until 2003, even though a Janssen-funded trial indicated the risk in 1997. In 2013, Janssen pleaded guilty to federal charges of misbranding the drug regarding the promotions to the elderly.

Marketed as an atypical anti-psychotic

Additionally, Janssen marketed Risperdal as an atypical anti-psychotic with low weight gain and diabetes risk. However, its internal studies indicated that after one year, patients on Risperdal had as much weight gain as its main competitor and a greater risk of diabetes.

“Going forward, we have tough terms in the settlement that will govern the way Risperdal can be marketed in the future here in Kentucky,” Attorney General Conway said. “It is my hope that the General Assembly will allocate the money to expand addiction treatment in Kentucky.”

In addition to the $15.5 million payment to settle the claims, Janssen is prohibited from promoting Risperdal for non-FDA approved uses or for populations in which it is not approved. Janssen will be required in Kentucky to clearly disclose risks associated with the drug. It will also not be allowed to promote the drug for a single symptom for which it is not approved, such as depression or anxiety, without reference to the underlying mental illnesses that Risperdal is approved by the FDA to treat.

The Food and Drug Administration (FDA) approved OxyContin in 1995. Following its release, Purdue immediately launched an aggressive national marketing campaign to promote the drug, which was led by sales representatives who falsely told doctors that OxyContin wasn’t addictive and was less likely to be abused than other opioid drugs.

Kentucky filed its lawsuit in 2007 to recover damages to the Commonwealth after Purdue pleaded guilty in U.S. District Court in the Western District of Virginia for misbranding OxyContin. In that case, three of its top executives also pleaded guilty to misdemeanor misbranding.

At the time, Kentucky was offered approximately $500,000 to settle its claims, which the Commonwealth refused. Now after eight years of hard-fought litigation, and while still facing significant legal issues in the case, Kentucky will receive $24 million. The agreement also extends injunctive relief that was set to expire in 2017. The court order directs the General Assembly to appropriate the funds to expand addiction treatment in Kentucky.

“Purdue Pharma created havoc in Kentucky, and I am glad it will be held accountable,” Attorney General Conway said. “Purdue lit a fire of addiction with OxyContin that spread across this state, and Kentucky is still reeling from its effects.”

In the settlement, Purdue does not admit wrongdoing. A copy of the settlement agreement is available here.

$500 million in settlements

ht years as Attorney General, Conway secured $500 million in consumer protection and Medicaid settlements. He increased Medicaid Fraud collections by 600 percent and investigated more elder abuse and neglect cases than any previous Kentucky Attorney General. He helped craft legislation that shut down half of the state’s pain clinics and worked to address the resurgence of heroin in Kentucky. He educated more than 45,000 parents, students and teachers about the dangers of prescription drug abuse through his “Keep Kentucky Kids” safe program. He secured Kentucky’s future tobacco payments by settling the Tobacco Master Settlement Agreement case. Attorney General Conway also led national efforts to investigate the practices of some for-profit colleges and shut down the website GIBill.com, which was a for-profit college lead generator masquerading as a government website. GIBill.com is now under the control of the U.S. Department of Veterans Affairs.

Attorney General Conway also created a Cybercrimes Unit that’s become a national model. The unit has a 100 percent conviction rate and has seized more than 1 million child pornographic images from the Internet.

“It’s been an honor to serve as Kentucky’s 49th Attorney General,” Attorney General Conway said. “I know that by working together, we’ve made Kentucky a safer place to live, work and raise a family.”

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Dozens of IVC filter lawsuits involving C.R. Bard Inc.’s retrievable inferior vena cava (IVC) filters continue to move forward in the multidistrict litigation underway in the U.S. District Court, District of Arizona. According to a Case Management Order dated December 17th, the Court has approved the use of Master Long Form and Short Form complaints. Beginning on December 28th, any plaintiff whose case would be subject to transfer to the multidistrict litigation may file directly in the Court via the Short Form Complaint. (In Re: Bard IVC Filters Products Liability Litigation – MDL No. 2641)

“Our firm is investigating a number of cases involving injuries allegedly caused by the tilting, fracture or migration of Bard IVC filters. The adoption of the Master and Short Form Complaints will do much to streamline the process for filing a claim in the federal litigation,” says Sandy A. Liebhard LLP, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently evaluating IVC filter lawsuits on behalf of individuals who may have been seriously injured by these products.

Pulmonary embolism

IVC filters are implanted in the inferior vena cava in patients at risk for a dangerous type of blood clot called a pulmonary embolism. Once implanted, the wire, cage-like device captures blood clots before they can travel to the lungs. Retrievable products, such as C.R. Bard’s Recovery and G2 IVC filters, are intended to be removed once the threat of pulmonary embolism has passed.

Court records indicate that at least 72 Bard IVC filter lawsuits have been filed in the litigation now underway in Arizona. Plaintiffs claim that a number of the company’s retrievable filters, including the Recovery and G2 devices, are associated with high rates of fracture, migration and tilting, which may result in perforation of the inferior vena cava, embolization and other life-threatening complications. They further allege that C.R. Bard has failed to provide doctors with adequate warnings regarding the importance of filter removal, as failure to retrieve an IVC filter in a timely manner greatly increases the risk of injury and complications.

Since 2010, the U.S. Food & Drug Administration (FDA) has issued two safety alerts regarding the use of retrievable IVC filters. In March 2010, the agency disclosed that it had received more than 900 adverse event reports involving the devices, including incidents of migration, fracture and embolization, and perforation of the inferior vena cava. In May of last year, the FDA issued a second notice to remind doctors that retrievable IVC filters should be removed within 29 to 54 days of their implantation.

Across the country, e-cigarettes are a booming business, popular with many segments of society. But as their popularity grows, so too does the risk to consumers. Defective e-cigarette products have, without warning, been violently exploding while charging and while in use. The explosions have caused burns, broken teeth, facial damage and even lit users and their surroundings on fire. And their hidden dangers aren’t limited to just explosions.

A new Harvard study, funded by the National Institute of Health, found that more than 75% of the flavored e-cigarette refill liquids tested contained a chemical called diacetyl, a major contributor to the potentially fatal lung disease Bronchiolitis Obliterans, better known as “Popcorn Lung.” The industry is all but unregulated, with few selling these dangerous products held accountable.

$1.885 million verdict

However, one recent verdict did just that. In the case of Jennifer Ries v. VAPCIGS, a young woman had an e-cigarette battery explode in her lap while riding as a passenger in a speeding vehicle. The exploding battery spewed flames and hot shrapnel over Ms. Ries’s legs, hand, and buttocks, in addition to causing her severe emotional trauma. Attorney Gregory L. Bentley of Shernoff Bidart Echeverria Bentley LLP, representing Ries, sought to impose products liability on the distributor, wholesaler, and retailer of the dangerous, defective product. Following a six-day jury trial, Bentley obtained the first-of-its-kind $1.885 million verdict against the entities responsible for distributing and selling the dangerous, defective e-cigarette.

Just one week before Christmas another explosion of an e-cigarette resulted in third degree burns to the face of Melinda Schaming. Melinda had fortunately just pulled the product out of her mouth when it exploded or the outcome could have been deadly. Ms. Schaming stated, “I want others to know how dangerous these products can be so that others don’t suffer similar injuries to mine or worse.”

Now, the law firms of Shernoff Bidart Echeverria Bentley LLP, Robinson Calcagnie Robinson Shapiro Davis, Inc., and the Pulaski Law Firm, PLLC “have joined forces to hold those who distribute, manufacture, and sell these dangerous, frightening products responsible for the injuries they are causing across the country,” said attorney Gregory Bentley. The firms are currently investigating more than 16 cases of e-cigarette explosions around the nation. Parties can call (800) 223-3784 or visit http://1800baddrug.com/e-cigarette-lawsuit/ to discuss a potential e-cigarette claim or for other questions you may have regarding this issue.

Bee Extremely Amazed LLC, Jewett, OH is voluntarily recalling various products marketed for weight loss to the consumer level due to findings of undeclared drug ingredients including sibutramine and/or phenolphthalein, according to an FDA report.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.

To date, Bee Extremely Amazed is not aware of any adverse event reports related to these products. See the Firm Press Release for a complete list of the recalled products.

Bee Extremely Amazed LLC is notifying its customers to stop using these products immediately and dispose of or return all recalled products to Bee Extremely Amazed 85205 Sportsmans Club Road Jewett Ohio 43986. Consumers with questions regarding this recall can contact Bee Extremely Amazed by email to sales@beeextremelyamazed.com or 1-844-427-6553Monday – Friday8:00 am – 4: 00 pm EST. Consumers should contact their physician or healthcare provider if they have any health questions or have experienced any problems that may be related to taking or using this product.

Two studies have brought new concerns to light regarding blood-thinner Xarelto and dangerous, uncontrollable bleeding episodes. Each study appears to link the anticoagulant to serious and even fatal side effects for patients taking it.

Xarelto was initially approved by the U.S. Food and Drug Administration in 2011, and was released to the market as a revolutionary new blood thinner. It was originally approved specifically to treat patients who had recently undergone hip or knee replacement surgeries, and this approved use was later expanded, approving the drug for patients with atrial fibrillation, pulmonary embolism, or deep vein thrombosis.

After only its first year on the market, the drug quickly became considered one of the most dangerous blood thinners. It was suddenly linked to hundreds of reports of adverse events, with patients claiming it had caused them blood clots, strokes, pulmonary embolisms, and other serious complications.

Eye bleeding

One study that illustrates problems with the drug was done by doctors Judy H. Hun and John C. Hwang. They noted that three of their patients had developed “spontaneous vitreous hemorrhage” (also known as eye bleeding) while using Xarelto. The doctors’ studies also concluded that the risk of eye bleeding may be increasingly elevated for patients who had switched from a traditional blood thinner, such as warfarin, to Xarelto.

Another study took place from October 1st 2010 to March 31st, 2012, and evaluated many people from the U.S. who were using Xarelto, Pradaxa, and Warfarin as blood thinners. The study details note that their final sample of patients included 46,000 total, 39,607 of which used warfarin, 4,907 of which used Pradaxa, and 1,649 of which used Xarelto. Research done on these individuals highlighted “as much as a 50% increase in the risk of gastrointestinal bleeding with dabigatran compared with warfarin or a more than twofold higher risk of bleeding with rivaroxaban (Xarelto) when compared with warfarin.”

Lawsuits filed against Xarelto now number near 2,000 in federal court. They have been consolidated to form multidistrict litigation number 2592, and are being overseen by Judge Eldon Fallon in the Eastern District of Louisiana. As they await trial, their numbers are only expected to increase.

Transvaginal mesh has been plagued by reports of devastating injuries among women who received the implants to treat pelvic organ prolapse or stress urinary incontinence, and to date, close to 80,000 lawsuits have been consolidated in six multidistrict litigations against mesh manufacturers like C.R. Bard, Coloplast, Ethicon, Boston Scientific and American Medical Systems.

All of the complaints involve similar allegations that the transvaginal mesh devices were defectively designed and caused serious side effects in users, and several vaginal mesh lawsuits have resulted in settlements or awards for the plaintiffs. If you received a transvaginal mesh implant in the past, and you have since suffered mesh infection, mesh erosion, or another major side effect, consult a skilled product liability lawyer today for legal help.

Transvaginal Mesh Verdicts and Settlements

In November 2015, the first transvaginal mesh lawsuit to go to trial over injuries from C.R. Bard’s Bard Avaulta mesh resulted in a $3.6 million verdict in favor of the plaintiff, for serious injuries like urination blockage and mesh erosion, which required eight revision surgeries to resolve. This was a landmark verdict for the ongoing transvaginal mesh litigation, and the evidence presented against Bard during the trial may set the stage for the more than 21,000 product liability lawsuits C.R. Bard still faces. Nearly 13,000 of these transvaginal mesh lawsuits have been consolidated in a federal court in Charleston, West Virginia, for coordinated pretrial proceedings as part of a multidistrict litigation (MDL).

Another recent surgical mesh lawsuit, brought against Boston Scientific over injuries from its Pinnacle and Advantage Fit devices, resulted in a $10 million award for the plaintiff, including $2.5 million in compensatory damages and $7.5 million in punitive damages designed to punish the mesh manufacturer for its deceptive actions and defective device. In the meantime, a transvaginal mesh trial involving Johnson & Johnson’s Ethicon unit is underway in a West Virginia federal court. The trial combines 37 complaints of the more than 23,000 product liability lawsuits pending against Ethicon for injuries allegedly caused by the medical device maker’s controversial Gynecaretransvaginal mesh implant.

Of all the transvaginal mesh manufacturers, Johnson & Johnson’s Ethicon unit has been the slowest to offer settlements, despite the fact that the company faces the highest number of federal lawsuits. J&J won the first surgical mesh bellwether trial just last year, and continues to contest liability for transvaginal mesh injuries suffered by patients, although it did agree to settle four claims for an undisclosed amount in January 2015. Another vaginal mesh maker, Coloplast, recently announced an increase of its transvaginal mesh litigation budget to $448 million, to cover the cost of surgical mesh settlement agreements. Coloplast already settled about 400 complaints last year, and currently faces another 2,000 lawsuits pending in the Southern District of West Virginia in a multidistrictlitigation.

A Skilled Transvaginal Mesh Attorney Can Help

In recent years, tens of thousands of transvaginal mesh lawsuits have been filed in state and federal courts across the country, on behalf of women who believe they have been injured by defective vaginal mesh implants, and several cases have already gone to trial, resulting in favorable verdicts for the plaintiffs, while others have been settled. If you believe you have suffered side effects oftransvaginal mesh, like mesh erosion, mesh infection or organ perforation, contact an experienced vaginal mesh attorney to discuss your options for legal recourse. With a qualified product liability lawyer on your side, you may be able to pursue financial compensation for your injuries and medical expenses.

The use of Bair Hugger forced-air warmers during surgery creates convection currents that capture particles below the surgical table, lifting them into the sterile surgical field, according to research recently published by orthopedic surgeons. The waste heat radiating through the surgical drape induced the formation of tornado-like vortexes of rapidly spinning air near the surgical site. The vortexes sucked contaminated air from the operating room floor and deposited it over the surgical wound.

2,000 times more contaminant particles were found in the air over the wound with Bair Hugger warming than with air-free HotDog conductive warming. With HotDog patient warming, only 1,000 particles per cubic meter of air were present. With Bair Hugger warming, the particle count was 2,174,000 per cubic meter, an increase of 217,300%.

Torso-style disposable blankets

Concerned by convection currents produced by hot-air warming devices, orthopedic surgeons A.J. Legg and A.J. Hamer from Northern General Hospital in Sheffield, United Kingdom, compared the torso-style disposable blankets of 3M’s Bair Hugger system with the reusable, air-free HotDog conductive warming system. The surgeons released particles below the surgical table and then measured how many were transported to the surgical site. Neither surgeon has any financial relationship with either of the products studied.

The study was published in the February issue of The Bone and Joint Journal and entitled “Forced-air patient warming blankets disrupt unidirectional airflow.”

Dr. Scott Augustine, inventor of both products studied, stated, “Such a massive increase in airborne contamination is obviously a safety issue in contamination-sensitive surgeries. In joint replacement surgery, for example, a single airborne bacterium can cause a deep joint infection.”

Periprosethetic joint infections are often catastrophic: immense pain and suffering, permanent disability and an enormous cost to the hospital.

“Every joint infection is a disaster—both for the patient and the system,” said Dr. Augustine. “The process is horrific: ex-plant the joint, prolonged hospitalization, 6-8 weeks of IV antibiotics and then—assuming no amputation—re-implant the joint. The average cost is around $100,000.” More than 12,000 of these infections occur each year in the US, a rate that some see as a significant public health problem.

A study conducted by other orthopedic surgeons and published in November 2011 in the Journal of Bone & Joint Surgery positively linked Bair Hugger warming to increased joint replacement infections. The surgeons showed that their deep joint infection rate dropped 74% when Bair Hugger warming was discontinued.

“While Bair Hugger has served most surgical patients well for the past 25 years,” said Dr. Augustine, “these two studies along with three others recently published clearly show that hot-air warming has unintended consequences and should never be used during total joint replacement surgery. Contamination of the sterile surgical field is a serious risk to patient safety.”

The BJJ article follows several other recently published, peer-reviewed studies in the Journal of Bone & Joint Surgery (Br), the American Journal of Infection Control, Anaesthesia, Orthopedic Review and Anaesthesia & Analgesia relating to the potential contamination of surgical sites by forced-air warming devices.
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BloodThinnerHelp.com reports on a recently filed Xarelto lawsuit which is quite different from most. The suit, which was filed on October 8th of 2015 against Bayer AG and Janssen Pharmaceuticals, alleges that Xarelto failed to prevent a stroke, because the drug did not last for an entire 24-hours as the package information indicates. While many have alleged that the once-daily dosage is not enough, this particular suit is notable as it provides supporting evidence of this factor. The plaintiff involved suffered a stroke just four days after starting Xarelto in order to prevent strokes due to his atrial fibrillation.

In details of his complaint, the plaintiff alleges that the blood-thinning drug was ineffective in preventing his stroke, and may have even caused the occurrence. Today, Xarelto is the subject of over 2,200 lawsuits in federal court. These suits similarly allege that Xarelto causes increased risk for uncontrollable bleeding episodes.

The United States Food and Drug Administration approved Xarelto in 2011. The pill was designed to prevent strokes and blood clots for patients who were recovering from hip and knee surgery or patients who had atrial fibrillation, a common heart condition. Initially, Xarelto was popular due to the fact that, unlike other blood thinners, it did not require special diets or regular monitoring.

No corresponding antidote

Many allegations in current Xarelto lawsuits have brought to light a major problem, which is that it was released to market with no corresponding antidote. Four years later,manufacturers have yet to provide one. Individuals using the drug who are injured and begin to bleed will be unable to get their blood to clot. Physicians treating them will have to resort to life-saving measures, such as blood transfusions or surgery to remove pressure and pooling blood.

Traditional blood thinners, quite differently, have an available antidote in vitamin K. If someone using this type of blood thinner begins to bleed, doctors can treat them with vitamin K, reversing the effects of the medication and clotting their blood. These blood thinners also require two doses of medicine daily, which the plaintiff in this particular lawsuit alleges may have prevented his stroke.

Xarelto bleeding lawsuits have been consolidated to form multidistrict litigation number 2592.They are being overseen by U.S. District Judge Eldon E. Fallon, and, at this time, bellwether trials for the cases are expected to begin in August of 2016.

San Diego, CA – December 11, 2015 – The market for diabetes drugs has never been stronger, and this demand has propelled sales of Johnson & Johnson’s hallmark diabetes drug Invokana along with a host of other new wave SGLT2 Inhibitors that include Farxiga, Jardiance, Xigduo, Invokamet, and Glyxambi.

Unfortunately, some 70 million people in developed regions, including North America and Europe, have been diagnosed with diabetes, and the global population of diabetics is expected to grow from 365 million people today to upwards of 550 million people by 2030. These trends and growth have provided drug manufacturers with serious incentive to get their drugs to the market as quickly as possible and questions are now being raised about the sufficiency and accuracy of the clinical trials that allowed these drugs to be approved by the FDA to begin with.

What are SGLT2 Inhibitors?

SGLT2 inhibitors are also known as gliflozins. They lead to a reduction in blood glucose levels. Therefore, SGLT2 inhibitors have potential use in the treatment of type II diabetes. As studied on Invokana (canagliflozin), a member of this class of drugs, gliflozins enhance glycemic control as well as reduce body weight and systolic and diastolic blood pressure. There are however serious concerns. The gliflozinscanagliflozin, dapagliflozin, and empagliflozin have been linked to diabetic ketoacidosis or DKA, a condition where acid levels in the blood become dangerously high.

Warning signs of ketoacidosis (DKA) include vomiting, nausea, trouble breathing, general confusion, abdominal and intestinal pains and severe fatigue. The FDA has urged patients who are taking any of the aforementioned diabetes medications and are suffering from any of these symptoms to seek medical attention immediately.

Dangerous Side Effects

Diabetic Ketoacidosis also known as DKA or Ketoacidosis is a condition in which high levels of ketones (chemicals that the body creates when it breaks down fat to use for energy) are produced in the body. Ketoacidosis is a condition that can result in a patient suffering diabetic coma, extended hospitalization and even death. Ketoacidosis develops when the body is unable to produce enough insulin, which insulin plays a major role in helping sugar (glucose) enter cells, and provides needed energy to the muscles and other tissues. Without enough insulin, the body breaks down fat as an alternative source of energy. This process produces a buildup of toxic acids in the bloodstream, ketones.

Kidney failure occurs when your kidneys stop functioning without the use of dialysis or a kidney transplant. Kidneys help filter waste products from the blood. They are also involved in regulating blood pressure, red blood cell production and electrolyte balance. If your kidneys fail to function properly, waste products, electrolytes and other fluids can build up in the body and can cause weakness, shortness of breath, fatigue, confusion, abnormal heart rhythms and death.

Myocardial infarction (MI) or acute myocardial infarction (AMI), commonly known as a heart attack, occurs when blood flow stops to a part of the heart causing damage to the heart muscle. The most common symptom is chest pain or discomfort which may travel into the shoulder, arm, back, neck, or jaw. Often it is in the center or left side of the chest and lasts for more than a few minutes.

Diabetes Medication Lawsuits

The diabetes medication lawsuits allege that the manufacturers and marketers of SGLT2 inhibitors (including as Johnson & Johnson, Janssen Pharmaceuticals Inc., AstraZeneca, etc.) failed to adequately research their drugs in clinical studies and that they did not warn physicians or patients of the increased risk of diabetic ketoacidosis (DKA), kidney failure, heart attack, stroke, and other dangerous side effects.

The lawsuits allege that if the manufacturers and marketers of these drugs had properly warned patients and doctors of the risks, there is a strong likelihood that doctors would have been more reluctant to prescribe the drugs, and that many of the patients would have been chosen a less dangerous alternative to treat their diabetes, and that they would likely have had relevant symptoms monitored on a more regular basis for potential signs of increased levels of ketones, heart concerns, and kidney impairment.